a trial to compare oxaliplatin, folinic acid (fa) and 5-fluorouracil (5fu) combination chemotherapy (folfox-4) with or without cetuximab in the 1st line treatment of metastatic colorectal cancer (mcrc) in chinese rat sarcoma viral oncogene homolog (ras) wild-type patients

Conditions: Metastatic Colorectal Cancer

Summary: the purpose of this study was to assess whether the progression free survival (pfs) time with folfox-4 plus cetuximab is longer than that with folfox-4 alone as first-line treatment for mcrc in chinese subjects with ras wild-type tumors.


Eligibility criteria:
inclusion criteria: * signed written informed consent (first and second) * chinese with chinese citizenship * male or female subjects greater than or equal to (\>=) 18 years of age * medically accepted effective contraception if procreative potential exists (applicable for both male and female subjects until at least 90 days after the last dose of trial treatment) * diagnosis of histologically confirmed adenocarcinoma of the colon or rectum * first occurrence of metastatic disease (not curatively resectable) ras wild-type status in tumor tissue * at least one measurable lesion by computer tomography (ct) or magnetic resonance imaging (mri) according to recist (not in an irradiated area) * life expectancy of at least 12 weeks * eastern cooperative oncology group (ecog) performance status of 0 or 1 at trial entry * white blood cell count \>= 3 × 10x9/l with neutrophils \>= 1.5 × 10x9/l, platelet count \>= 100 × 10x9/l and hemoglobin \>= 6.21 mmol/l (10 g/dl) * total bilirubin \<= 1.5 × upper limit of reference range * aspartate transaminase (ast) and alanine transaminase (alt) \<= 2.5 × upper limit of reference range or \<= 5 × upper reference range in subjects with liver metastasis * serum creatinine \<= 1.5 × upper limit of reference range * recovery from relevant toxicity due to previous treatment before trial entry exclusion criteria: * previous chemotherapy for crc except adjuvant treatment if terminated \> 9 months (oxaliplatin-based chemotherapy) or \> 6 months (non-oxaliplatin-based chemotherapy) before the start of treatment in this trial * radiotherapy or surgery (excluding prior diagnostic biopsy) in the 30 days before trial treatment * previous treatment with monoclonal antibody therapy, vascular endothelial growth factor (vegf) pathway-targeting therapy, epidermal growth factor receptor (egfr) pathway-targeting therapy, or other signal transduction inhibitors * history of organ allograft, autologous stem cell transplantation, or allogeneic stem cell transplantation * renal replacement therapy * intake of any investigational medication within 30 days before trial entry * concurrent chronic systemic immune therapy or hormone therapy except physiologic replacement * granulocyte colony stimulating factor (g-csf) or granulocyte macrophage colony stimulating factor (gm-csf) within 3 weeks of trial entry (these growth factors may be used during the trial thereafter) * other non-permitted concomitant anticancer therapies * known brain metastasis and/or leptomeningeal disease. subjects with neurological symptoms should undergo a ct scan/mri of the brain to exclude brain metastasis * previous malignancy other than crc in the last 5 years except basal cell cancer of the skin or preinvasive cancer of the cervix * clinically significant cardiovascular disease, e.g. cardiac failure of new york heart association classes iii-iv, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 5 years, or left ventricular ejection fraction below the institutional range of normal on a baseline multiple gated acquisition scan or echocardiogram * acute or sub-acute intestinal occlusion or history of inflammatory bowel disease * active clinically serious infections (\> grade 2 national cancer institute-common terminology criteria for adverse events (nci-ctcae) version 3.0), including active tuberculosis * known and declared history of human immunodeficiency virus (hiv) infection or chronic hepatitis b or c * peripheral neuropathy \> grade 1 * signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such * uncontrolled diabetes mellitus, pulmonary fibrosis, acute pulmonary disorder, interstitial pneumonia, or liver failure * known hypersensitivity or allergic reactions against any of the components of the trial treatments * pregnancy (absence to be confirmed by serum β-human chorionic gonadotropin test) or breastfeeding * ongoing alcohol or drug abuse * presence of a medical or psychological condition that would not permit the subject to complete the trial or sign informed consent * participation in another clinical trial within the past 30 days * other significant disease that in the investigator's opinion should exclude the subject from the trial * legal incapacity or limited legal capacity

Keywords: metastatic colorectal cancer ras wild type cetuximab first line treatment first occurrence of metastatic colorectal cancer in chinese subjects with ras wildtype status